Pharma Industry News

FDA Issues Complete Response Letters Ordering Safety Labeling Changes Under FDAAA for Aranesp, Epogen, and Procrit

Follow Up to the January 3, 2008 Communication About an Ongoing Safety Review Erythropoiesis-Stimulating Agents (ESAs) Epoetin alfa (marketed as Procrit, Epogen) Darbepoetin alfa (marketed as Aranesp)

This information reflects FDA’s current analysis of available data concerning these drugs. FDA intends to update this document when additional information or analyses become available.

ROCKVILLE, Md., July 30, 2008--On April 22, 2008, FDA notified the manufacturer of Epogen/Procrit and Aranesp of its decision to require additional safety-related changes to the labeling for these products.

Amgen submitted labeling supplements for Epogen/Procrit and Aranesp on May 22, 2008, following the March 13, 2008 Oncologic Advisory Committee’s recommendations to make additional safety-related changes to the labeling for these products. Amgen and FDA have agreed on many of these changes, including to replace the existing Patient Package Insert with a Medication Guide and to modify certain sections of the Boxed Warnings, Indications and Usage, and Dosage and Administration sections of package insert.

These changes are intended to clarify the FDA-approved conditions for use of ESAs in patients with cancer and revise directions for dosing to state the hemoglobin level at which treatment with an ESA should not be initiated. While agreement was reached on the general concepts, Amgen and FDA have not reached agreement on specific wording on two points, including a warning statement that ESAs are not intended for use in patients receiving myelosuppressive therapy when the expected outcome is cure and statements regarding when to initiate and to discontinue ESA dosing. Labeling discussions concluded on July 15 and FDA issued a letter ordering the additional changes on July 30, 2008.

FDA’s action to require these safety labeling changes follows the completion of the review of information received in November 2007 and December 2007 and are in keeping with the recommendations made at the March 13, 2008 Oncologic Drugs Advisory Committee meeting. Amgen has been ordered to make the additional changes under new authorities provided in the FDA Amendments Act of 2007 and has 5 days to appeal or 15 days to submit a supplement containing the labeling changes.

FDA continues to encourage healthcare professionals to discuss with their patients before starting or continuing therapy with ESAs, the benefits of treatment with ESAs and the potential and demonstrated risks of ESAs for thrombovascular events, shortened time to tumor progression or recurrence, and shortened survival time.

The FDA urges healthcare professionals to promptly report serious and unexpected adverse reactions associated with Epogen, Procrit and Aranesp to the FDA MedWatch reporting program, as described below.

online at www.fda.gov/medwatch/report.htm
by returning the postage-paid FDA form 3500 (available in PDF format at www.fda.gov/medwatch/getforms.htm) to 5600 Fishers Lane, Rockville, MD 20852-9787
faxing the form to 1-800-FDA-0178
by phone at 1-800-332-1088